K183152 · Us Bionics, Inc. (Dba Suitx) · PHL · Apr 17, 2019 · Physical Medicine
Device Facts
Record ID
K183152
Device Name
Phoenix
Applicant
Us Bionics, Inc. (Dba Suitx)
Product Code
PHL · Physical Medicine
Decision Date
Apr 17, 2019
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.3480
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Phoenix orthotically fits to the lower limbs and trunk. The device is intended to enable individuals with spinal cord injury at levels T4 to L5 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. This device is not intended for sports or stair climbing.
Device Story
Phoenix is a wearable, powered exoskeleton assisting trained users with SCI (T4-L5) to sit, stand, walk, and turn in rehabilitation institutions. System comprises motorized leg braces, torso module, lithium-ion battery, main controller, and wireless user interface (crutch/walker-mounted) paired with an Android tablet app. Clinicians operate the device, adjusting modular components (spine, hip, femur, tibia, footplate) and soft-good straps to fit patients. Device provides auditory feedback and LED indicators to the wearer. In power failure, knees lock and hips remain free. System requires mandatory clinician-led training and certification. Output enables patient ambulation, potentially improving mobility and functional independence. Safety is maintained by a required spotter/therapist during use.
Clinical Evidence
Prospective clinical study of 40 subjects with SCI (T4-L5). Primary endpoints: safety and effectiveness for transitional movements and walking. Results: 10MWT mean speed 0.12 m/s (±0.06); mean FIM 4.6 (±0.50). 6MWT mean FIM 4.37 (±0.49). TUG test: 39/40 subjects completed with minimal assistance, 1 with moderate assistance. Adverse events limited to minor bruising from improper fit; no unanticipated adverse events. Study confirms safety and effectiveness for intended use.
Technological Characteristics
Powered exoskeleton; modular adjustable aluminum/mechanical frame; lithium-ion battery (51.8V, 113Wh); motorized hip/knee actuators. Connectivity: wireless interface to Android tablet. Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), UN 38.3/ISO 62133 (battery). Software: control system for gait/transitions. Cleaning: alcohol-based solution compatible.
Indications for Use
Indicated for adults over 18 with spinal cord injury (SCI) at levels T4 to L5 to perform ambulatory functions in rehabilitation institutions. Contraindicated for sports or stair climbing.
Regulatory Classification
Identification
A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.
Special Controls
In combination with the general controls of the FD&C Act, the Powered Exoskeleton is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
*i.e.,* cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
*e.g.,* indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how to program the device;
(D) Instructions and explanation of all controls, input, and outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
*e.g.,* EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
*e.g.,* level of supervision or assistance, and environment of use (*e.g.,* indoors and/or outdoors) including obstacles and terrain).
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## 510(k) Summary as required by 21 CFR 807.92 K183152
#### Submission Information ਹ
### 1.1 Device Name
Phoenix™
### 1.2 Submission Sponsor
US Bionics, Inc. (DBA suitX) 4512 Hollis Street Emeryville, CA 94608
Homayoon Kazerooni, PhD Founder & CEO 1.510.610.2188 info@suitx.com
### 1.3 Submission Contact
Official Contact Kelly Mettler Director of Regulatory Affairs and Quality Assurance Regulatory@suitx.com
### Representative/Consultant
Allison C. Komiyama, Ph.D., R.A.C. AcKnowledge Regulatory Strategies, LLC Principal Consultant 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110, USA 1.619.458.9547 info@acknowledge-rs.com https://www.acknowledge-rs.com
### 1.4 Submission Preparation Date
K183152 – 15 April 2019
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#### 2 Device Identification
| Trade Name: | Phoenix™ |
|------------------------|------------------------------|
| Common Name: | Powered Exoskeleton |
| Manufacturer: | US Bionics, Inc. (DBA suitX) |
| Classification Name: | Powered Exoskeleton |
| Device Classification: | Class II, 21 CFR 890.3480 |
| Product Code: | PHL |
#### Legally Marketed Predicate Device 3
| Trade Name: | Indego® |
|----------------------|-----------------------------------------------|
| Manufacturer: | Parker Hannifin Corporation (Parker Hannifin) |
| Classification Name: | Powered Exoskeleton |
| 510k Number: | K152416 |
| Submission Date: | 2/26/2016 |
#### Device Description 4
The Phoenix™ is a wearable, powered exoskeleton that assists a trained user to sit, stand, walk, and turn. The Phoenix consists of a pair of motorized leg braces coupled to a torso module, a lithium-ion battery pack, a main controller unit, and a wireless user interface attached to the handle of an assistive device (such as a crutch, walker, or parallel bars), control software, and mobile Android tablet hosting a mobile app. The Phoenix dimensions, such as spine length, torso hip width, femur length, femur bracket, tibia length, tibia bracket, and foot plate length can be adjusted individually. The Phoenix is coupled to the user via soft-good components (i.e. shoulder straps, waist pads, thigh straps, and shin pads), which can be adjusted to accommodate various users' dimensions.
#### 5 Indication for Use
The Phoenix orthotically fits to the lower limbs and trunk. The device is intended to enable individuals with spinal cord injury at levels T4 to L5 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. This device is not intended for sports or stair climbing.
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#### б Training
Training is a critical and required component of using the Phoenix™ exoskeleton. Patients and Clinicians must undergo training developed by suitX to learn proper use of the Phoenix device. The four-phase training program described in this guide is designed for training clinicians on the proper use and fit of the Phoenix. Refer to Table 1 below for the training sequence.
Table 1 Clinical Certification Training 4 Phase Training Program
- Device Overview
- Demonstration of ExoControl App Use
- Patient Measurement
- Tibia Length O
- Femur Length O
- Torso Width O
- Torso Height O
- Adjustment of Phoenix to fit Patient
- Leg Adjustment O
- Torso Adjustment (Width and Height)
- Footplate Adjustment O
- Safeguard Patient during maneuvers
- Standing Up O
- Walking O
- 0 Turning
- Sitting down O
- Documentation of settings, measurements, ● and outcomes (patient's maneuvers).
- Practice setting up and conducting an entire test session
- Review of phase 1 and 2 training ●
-
- Review of phase 1 training ●
- Session preparation and procedure ●
- Practice donning the device ●
- Practice resting while standing ●
- . Review of fail-safe sitting procedure
- Review of what to do in case of fall ●
- Demonstrate storage of device .
- Review troubleshooting of device
Image /page/3/Picture/35 description: The image contains a black number four inside of a black circle. The number is centered inside the circle. The background of the image is white.
- Review of any outstanding questions from phase 1-3
- . Certification
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Image /page/4/Picture/0 description: The image shows the logo for "SUITX". The word "SUIT" is in black, blocky, sans-serif letters. The "X" is in red and is stylized to look like two intersecting lines. The logo is simple and modern.
### Substantial Equivalence (SE) Discussion 7
The following table compares the Phoenix™ to the predicate device with respect to indications for use, principles of operation, technological characteristics, materials, and performance testing. The technological similarities between the subject device and the predicate device are substantially equivalent. The subject device does not raise any new issues of safety or effectiveness. Table 1, below, provides a summary comparison of the technological characteristics.
| Manufacturer | SuitX | Parker Hannifin | Significant Differences |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Phoenix Medical<br>Exoskeleton | Indego® | |
| 510(k) Number | K183152 | K152416 | N/A |
| Product Code | PHL | PHL | Same |
| Regulation<br>Number | 890.3480 | 890.3480 | Same |
| Regulation<br>Name | Powered Exoskeleton | Powered Exoskeleton | Same |
| Indications for<br>Use | The Phoenix Medical<br>Exoskeleton orthotically<br>fits to the lower limbs and<br>the trunk; the device is<br>intended to enable<br>individuals with spinal cord<br>injury at levels T4 to L5 to<br>perform ambulatory<br>functions in rehabilitation<br>institutions in accordance<br>with the user assessment<br>and training certification<br>program. This device is not<br>intended for sports or stair<br>climbing. | The Indego® orthotically<br>fits to the lower limbs and<br>the trunk; the device is<br>intended to enable<br>individuals with spinal cord<br>injury at levels T7 to L5 to<br>perform ambulatory<br>functions with supervision<br>of a specially trained<br>companion in accordance<br>with the user assessment<br>and training certification<br>program. The device is also<br>intended to enable<br>individuals with spinal cord<br>injury at levels T4 to T6 to<br>perform ambulatory<br>functions in rehabilitation<br>institutions in accordance<br>with the user assessment<br>and training certification<br>program. The Indego is not<br>intended for sports or stair<br>climbing. | Similar; the Phoenix<br>indications for use are<br>the same as the<br>predicate device when<br>used in rehabilitation<br>institutions. |
| Manufacturer | SuitX | Parker Hannifin | Significant Differences |
| Trade Name | Phoenix Medical<br>Exoskeleton | Indego® | |
| Body Coverage | Worn over legs and around<br>hips and lower torso;<br>shoulder straps for<br>additional stability | Worn over legs and around<br>hips and lower torso | Similar; the components<br>are worn around the<br>legs and torso with the<br>control unit of the<br>device integrated into<br>the hip segment. A rigid<br>back is connected to the<br>hip segment and worn<br>in a similar fashion as a<br>backpack. The rigid back<br>of the torso module of<br>the Phoenix is similar to<br>other FDA cleared<br>exoskeletons including<br>the EKSO (K161443) and<br>REWALK (K160987). No<br>additional safety or<br>efficacy concern as the<br>component<br>configuration is similar<br>for the legs, hip, and<br>torso of the patient. |
| Size of<br>Components | Modular Adjustable<br>Medium, and Large upper<br>leg, lower leg; and<br>adjustable torso<br>components; control unit<br>integrated in torso unit | Modular Small, Medium,<br>and Large upper leg, lower<br>leg, and hip components;<br>control unit integrated in<br>hip unit | Similar; adjustability<br>provided by manually<br>adjusting the length of<br>hard components.<br>Control unit is<br>integrated in hip unit.<br>No additional safety or<br>efficacy concern as the<br>component<br>configuration is similar<br>for the legs, hip, and<br>torso of the patient. |
| Mobility Aid | Crutches or walkers | Crutches or walkers | Same |
| Ability of User<br>Mobility | Sit, stand, walk, and turn | Sit, stand, walk, and turn | Same |
| Walking Speed | ~ 2 km/hr. | ~ 2 km/hr. | Same |
| Grade<br>Inclination | 5 degrees | 5 degrees | Same |
| Manufacturer<br>Trade Name | SuitX<br>Phoenix Medical<br>Exoskeleton | Parker Hannifin<br>Indego® | Significant Differences |
| Type of<br>Surface | Smooth, cement, carpet | Smooth, grass, cement,<br>carpet, transitions,<br>thresholds | Similar; the Phoenix<br>surface types are the<br>same as the predicate<br>device when used in<br>rehabilitation<br>institutions. |
| Patient<br>Population | Adults over age of 18 with<br>Spinal Cord Injury (SCI)<br>from T4 to L5 | Adults over age of 18 with<br>Spinal Cord Injury (SCI)<br>from T4 to L5 | Same |
| Height of<br>Patient | 61" to 75" (1.55 to 1.91m) | 61" to 75" (1.55 to 1.91m) | Same |
| Weight of<br>Patient | Up to 200 lbs. (90.7 kg) | Up to 250 lbs. (113 kg) | Similar; the device<br>accommodates lighter<br>weight patients and<br>does not present any<br>additional safety or<br>efficacy concerns. |
| Control<br>Method | Remote control on the<br>walker or crutch to trigger<br>all transitions | Uses postural cues to<br>trigger all transitions | Similar; the remote<br>control provides the<br>trained user direct<br>control over the device<br>operation. Additionally,<br>the remote control is<br>used to trigger sit-to-<br>stand and stand-to-sit.<br>No additional safety or<br>efficacy concerns have<br>been identified. |
| Range of<br>Motion | Hip: 140° flexion to 38°<br>extension<br>Knees: 110° flexion to 5°<br>extension | Hip: 110° flexion to 30°<br>extension<br>Knees: 110° flexion to<br>10° extension | Similar; there is a larger<br>range of motion for the<br>Phoenix device to allow<br>easier sit-to-stand<br>transitions. No<br>additional safety or<br>efficacy concerns as<br>clinical data supports<br>the safe use of the<br>device for ambulation<br>and sitting/standing<br>transitions. |
| Manufacturer<br>Trade Name | SuitX<br>Phoenix Medical<br>Exoskeleton | Parker Hannifin<br>Indego® | Significant Differences |
| Weight | 33 lbs. (15kg) | 26 lbs. (12kg) | Similar; the device<br>weighs more than the<br>predicate device but<br>within predicate range<br>of exoskeleton devices<br>(26 lbs. - 66 lbs.). |
| Rechargeable<br>Battery | Rechargeable lithium ion.<br>51.8 V, 10A peak current,<br>10A continuous current,<br>113Wh fully charged; 4<br>hours of continuous<br>walking per charge | Rechargeable lithium<br>ion. 33.3V, 36A peak<br>current, 12A continuous<br>current. 159Wh fully<br>charged; 1.5 hours of<br>continuous walking per<br>charge | Similar; the phoenix<br>battery is slightly<br>smaller but provides the<br>necessary power for the<br>operation of the device.<br>No additional safety or<br>efficacy concerns. |
| Battery Charge<br>Time | Maximum of 2 hours | Maximum of 4 hours | Similar; the Phoenix<br>battery is able to be<br>charged in a slightly<br>faster period of time.<br>No additional safety or<br>efficacy concerns. |
| Expected<br>Useable Life | 5 years | 5 years | Same |
| Training<br>Program | Yes | Yes | Same |
| Certification<br>Program | Yes | Yes | Same |
| User Feedback | Provides auditory feedback<br>and LED indicators on top<br>of hip unit, visible to the<br>wearer | Provides vibratory<br>feedback and LED<br>indicators on top of hip<br>unit, visible to the wearer | Similar; auditory<br>feedback provides the<br>user with critical safety<br>information; both<br>devices provide LED<br>indicators to<br>communicate<br>information to the user.<br>No additional safety or<br>efficacy concerns. |
| Manufacturer | SuitX | Parker Hannifin | |
| Trade Name | Phoenix Medical | Indego® | Significant Differences |
| | Exoskeleton | | |
| Fall Detection<br>and Mitigation | Detects posture and<br>prevents user from<br>standing up if improper<br>posture is detected.<br>Automatic User Interface<br>timeout reduces the risk of<br>falling due to accidental<br>user inputs. Fall protection<br>is provided by the<br>Healthcare<br>Professional/Physical<br>Therapist (PT). Device does<br>not have fall detection<br>features. | Detects forward, backward,<br>and sideways falling as it is<br>happening; the device<br>makes adjustments during<br>the course of the fall to<br>position the user for<br>minimal risk of injury | Different; the Phoenix<br>device will notify the<br>user after detecting<br>improper positioning to<br>prevent the risk of<br>injury during standup.<br>While standing or<br>walking, fall protection<br>and mitigation is<br>provided by the<br>Healthcare Professional/<br>Physical Therapist (PT).<br>No additional safety or<br>efficacy concerns have<br>been identified as both<br>devices require a<br>spotter to guard against |
| Failsafe<br>Feature | In the event of power<br>failure – knees become<br>locked and hips free<br>(similar to typical passive<br>leg braces) | In event of power failure -<br>knees become locked and<br>hips free (similar to typical<br>passive leg braces) | falls.<br>Same |
| Operating<br>Temperature | 32°F to 88°F (0°C to 31°C) | 32°F to 88°F (0°C to 31°C) | Same |
| Operating<br>Humidity | 30% to 75% RH | 30% to 75% RH | Same |
| Electrical<br>Safety Testing | Passed IEC 60601-1:2005<br>(3rd Edition) + CORR.<br>1:2006 + CORR. 2:2007 +<br>A1:2012 (or IEC 60601-1:<br>2012 reprint) | Passed ANSI/AAMI<br>ES60601-<br>1:2005/(R)2012 | Similar; tested to<br>newest version of the<br>standard |
| Electromagnetic<br>Compatibility<br>Testing | Passed IEC 60601-1-2:2014<br>(4TH Edition) | Passed IEC 60601-1-<br>2:2007 | Similar; tested to<br>newest version of the<br>standard |
| Technical Area | Test Completed | Results | |
| Electrical Safety<br>Testing | IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012<br>(or IEC 60601-1: 2012 reprint) | PASS | |
| Electromagnetic<br>Compatibility Testing | IEC 60601-1-2:2014 (4th Edition)<br>AAMI/TIR69:2017 - Medical Devices - Risk Management of Radio-<br>Frequency Wireless Coexistence | PASS | |
| Battery Safety Testing | UN 38.3, ISO 62133 | PASS…
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
